MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. DUODENOVIDEOSCOPE

Model Number	TJF-150
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B2) date of event is unknown.Additional information will be provided if available.Based on the completed investigation, the identity of the foreign material and the root cause of why it remained in the device could not be definitively determined.However, it is likely that the user deviated from the ifu (instruction for use) prior to sending the device to olympus.This event is detectable and preventable by handling device in accordance with the following ifu: ifu document no.: rc3954 rev.: 2 section: chapter 3 preparation and inspection ifu document no.: rc3955 rev.: 1 section: chapter 3 cleaning, disinfection and sterilization procedures should any additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
The customer returned the gastrointestinal videoscope to the service center for a separate issue.During the device analysis, the technician indicated that there were foreign objects on the knob wire due to improper reprocessing.There was no patient involvement.

• Brand Name: DUODENOVIDEOSCOPE
• Common Device Name: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 25397730
• Report Number: 9610595-2026-45786
• Device Sequence Number: 13441540
• Product Code: FDT
• UDI-Device Identifier: 04953170307553
• UDI-Public: 04953170307553
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: TJF-150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown